Identity
- Trade Name
- Insight Discovery Dual Inclinometer FDA UDI
- Generic Name
- Biomechanical function analysis system, motion-tracking FDA UDI
- Model / Reference
- 900-024-2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00890477000104 FDA UDI
- 510(k) Number
- K063447 FDA UDI
- FDA Product Code
- HCC FDA UDIIKN FDA UDI
- GMDN Term
- Biomechanical function analysis system, motion-tracking FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5050 FDA UDI890.1375 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: ElectromyographElectronic goniometer/kinesiology sensorBiofeedback system application softwareBiomechanical function analysis system, motion-tracking
Insight Discovery Dual Inclinometer by SRS Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K063447 also covers:
- Discovery Base Unit — SRS Medical Systems, Inc.
- EMG Sensor — SRS Medical Systems, Inc.
- Insight Discovery Algometer — SRS Medical Systems, Inc.
- Insight Discovery EMG — SRS Medical Systems, Inc.
- Insight Discovery PWP — SRS Medical Systems, Inc.
- Insight Discovery PWP (w/cable) — SRS Medical Systems, Inc.
- Insight Discovery Thermal — SRS Medical Systems, Inc.
- Insight Discovery Thermal (w/cable) — SRS Medical Systems, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- SRS Medical Systems, Inc.
Sources (1)
- FDA UDI 18b8975f-d5a5-45dd-bae0-65be259d3271 33 fields · synced Jun 7, 2026